LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251997
    Device Name
    Single-Use Biopsy Valve (MAJ-1555)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-09-25

    (90 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K182275
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SINGLE USE BIOPSY VALVE MAJ-1555 has been designed to be attached to the instrument channel port of the endoscopes and to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.

    Device Description

    The Olympus Single Use Biopsy Valve MAJ-1555 is a sterile, disposable device designed to attach to the instrument channel port of Olympus endoscopes. It facilitates the passage and exchange of endoscopic devices, helps maintain insufflation, minimizes leakage of biomaterial, and prevents reflux of body fluids. The device consists of a cap and inner rubber made of silicone rubber, and a housing made of polyethylene. A lever mechanism prevents reuse after detachment.

    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1